Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease
Overview
- Phase
- Phase 2
- Intervention
- Ciprofloxacin
- Conditions
- Crohn Disease
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.
Investigators
Eligibility Criteria
Inclusion Criteria
- •CD of the ileum, with or without involvement of the caecum or the right colon
- •Colonoscopy showing active lesions defined by a CDEISm score \>6
- •Informed consent to participate in this study
- •Prescription of steroid treatments : Budesonide, Prednisone (or Prednisolone) independently from entry in study
- •Patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in CDAI between the pre-inclusion and the inclusion visit,
- •Patients colonized with AIEC on initial ileal biopsies.
Exclusion Criteria
- •Ileal stenosis that cannot be crossed by the endoscope,
- •Infliximab treatment received less than 8 weeks before inclusion in this study,
- •Adalimumab treatment received less than 4 weeks before inclusion in this study,
- •Vedolizumab treatment received less than 8 weeks before inclusion in the study,
- •Hypersensitivity to Ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide E171, macrogol 4000,),
- •Tizanidine, Probenecid, Theophylline, Xanthine derivatives, Phenytoin, oral anticoagulants, and Ropinirole treatment,
- •Hypersensitivity to Rifaximin, or to any excipients (sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide, disodium edentate, propylene glycol, red iron oxide E172),
- •Previous extensive ileal surgery (≥ 1 meter as measured on the pathology and/or surgical report),
- •Short bowel syndrome,
- •Need for an intestinal resection for fistula, abscess or intestinal obstruction,
Arms & Interventions
Experimental arm
oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks
Intervention: Ciprofloxacin
Experimental arm
oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks
Intervention: Rifaximin
Control arm
a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks
Intervention: Ciprofloxacin Placebo
Control arm
a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks
Intervention: Rifaximin Placebo
Outcomes
Primary Outcomes
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
Time Frame: week 12
(assessed within each site quotation), defined by the modified Crohn's Disease Endoscopic Index of Severity (CDEISm)\< 6 and a decrease in CDEISm ≥ 3, as compared to baseline values.
Secondary Outcomes
- Microbiota composition(weeks 12 and 48)
- No ulceration(week 12)
- Complete endoscopic remission(week 12)
- Biological remission(weeks 4, 8, 12, 24, 36 and 48)
- Mean variation of CDEISm(week 12)
- Clinical remission(12 and 48 weeks)
- lpf positive AIEC bacteria in the stools(weeks 12 and 48)
- Side effects(week 12)